Boehringer Ingelheim biosimilars news
Boehringer Ingelheim disclosed that it is conducting Phase III trials evaluating biosimilars of autoimmune drug Humira adalimumab, cancer drug Avastin bevacizumab and autoimmune and cancer drug Rituxan rituximab. Boehringer and partner Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.) are also developing LY2963016, a basal insulin glargine analog that has the same amino acid sequence as Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY, Paris, France). In December, FDA accepted an NDA for LY2963016 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products. The PDUFA date is not disclosed. LY2963016 is also under review in Europe. The companies partnered in January 2011 to co-develop and co-commercialize a portfolio of diabetes candidates, including LY2963016 (see BioCentury, Jan. 17, 2011 & Jan. 6, 2014).
AbbVie Inc. (NYSE:ABBV, Chicago, Ill.) markets Humira in the U.S. and EU. The company reported $10.7 billion in Humira sales in 2013. Eisai Co. Ltd. (Tokyo:4523, Tokyo, Japan) and Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) jointly developed Humira and co-promote it in Japan, Korea and Taiwan. Abbott has rights to the product elsewhere. Abbott spun out its pharmaceuticals business into AbbVie last year. ...